ICU Medical 42800-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709098077), received between Jul 11, 2023 and Apr 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLUSH DEVICE, MACRODRIP WHERE THE CUSTOMER STATED IN THE REPORT WITH YNHHS TRACKER # (B)(4) AND SAFER # (B)(4) THAT AN A-LINE SETUP WAS DEFECTIVE WITH A BREAK IN THE SYSTEM RESULTED IN LEAKING. THE PATIENT DETERIORATED DURING THE DAY AND A-LINE WAS CHANGED DURING CHANGE OF SHIFT. TINY BREAK IN A-LINE TUBING AND IT WAS NOTED AFTER ATTACHED TO THE PATIENT. THIS WAS A TRANSDUCER TUBING USED FOR ARTERIAL BLOOD PRESSURE MONITORING. THE TEAMS IDENTIFIED THAT IT WAS LEAKING AT ONE OF THE CONNECTIONS AFTER THE RN COULD NOT FLUSH THE TRANSDUCER TUBING. THE STATUS OF THE PRODUCT WAS THAT IT WAS IN USE ON THE PATIENT FOR MONITORING AS INDICATED. THE LEAK CAME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER AND AT THE TIME, IT WAS IDENTIFIED THAT THE NORMAL SALINE USED WITH THE TRANSDUCER SET UP WAS LEAKING SO THIS COULD HAVE AFFECTED THE RN. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055404 ↗
• MalfunctionJul 11, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLUSH DEVICE, MACRODRIP WHERE IT WAS REPORTED THAT THE THE TUBING THAT SEATS INTO THE STOPCOCK CAME LOOSE WITHOUT ANY FORCE. SINCE ARTERIAL LINE TRANSDUCER SAFESET IS HOOKED UP DIRECTLY TO THE PATIENT'S ARTERY VIA CATHETER BLOOD WAS POURING FROM THE FAILED STOPCOCK. DURING THE CASE WHEN THE ANESTHESIOLOGIST WENT TO USE THE SYRINGE TO DRAW BACK FOR LABS, HE ATTACHED THE SYRINGE TO THE STOPCOCK THAT IS SPECIFICALLY USED FOR DRAWING THE SAMPLE. THEY CLAMPED OFF THE REMAINING TUBING AND SPIKED A WHOLE NEW SET AND HOOKED IT UP TO THE PATIENT. IT WAS MENTIONED THAT, THIS IS DURING A CASE IN THE OR THAT NEEDED AN ALINE THEY HOOKED UP THE PATIENT TO THE SAFESET AND AT THE STOPCOCK WHERE THE TUBING CONNECTS CAME APART AND IT APPEARS THAT THE TUBING DIDN'T HAVE THE PROPER EPOXY/ADHESIVE TO ADEQUATELY ADHERE TO EACH OTHER. AS A RESULT SHORTLY AFTER, IT CAME APART WITH LITTLE RESISTANCE AND IT STARTED BLEEDING BACK. THERE WAS PATIENT INVOLVED AND NO HUMAN HARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303327 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06